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Completed

NCT Number: NCT01423617

Efficacy and Safety of Zenoctil in Reducing Body Weight

The intention of the study is to evaluate the safety and potential body weight and body fat loss effects of a 12-week treatment with Zenoctil in a randomized, double-blind, placebo-controlled, parallel study conducted in Caucasian subjects.

This study will also include a diet plan for each subject, calculated based on gender, age, and energy requirements; and adjusted to be slightly hypocaloric.

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Key information

Conditions

Overweight Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Barbara Grube

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caucasian males and females, age 18 to 60 years
  • 25 kg/m2 ≤ BMI ≤32 kg/m2
  • Expressed desire for weight loss
  • Accustomed to 3 main meals a day
  • Consistent and stable body weight 3 months prior to study enrollment
  • Commitment to avoid the use of other weight loss products/programs during the study
  • Commitment to adhere to diet recommendation
  • Females' agreement to use appropriate birth control methods during the active study period
  • Subject declares in writing his/her consent to participate, understands requirements of the study and is willing to comply

Exclusion criteria

  • Known sensitivity to Garcinia cambogia, Lagerstroemia speciosa (other members of Lythraceae family), caffeine, tannins
  • History of diabetes mellitus or other endocrine disorders
  • Fasting blood glucose >7 mmol/L
  • Treatment with systemic corticosteroids within the last 12 months
  • Current use of antidepressants
  • Uncontrolled hypertension (>160/110) or other uncontrolled cardiac, pulmonary, renal, or liver disease, determined to be clinically significant by the investigator
  • Presence of acute or history of chronic gastrointestinal disease
  • Schizophrenia or other diagnosed psychiatric disorders
  • Any other acute or chronic disease or any other medical condition which, in the investigator's view, may preclude subject's inclusion (e.g., cancer, HIV)
  • Bariatric surgery
  • Abdominal surgery within the last 6 months
  • History of eating disorders like bulimia, anorexia nervosa
  • Changes in the dose of estrogen, contraceptives or thyroid hormone within the last 3 months
  • Pregnancy or nursing
  • Any medication or use of products for the treatment of obesity (e.g., fat binder, carbohydrate blocker/starch blocker, fat burner, satiety products etc.) within the last 6 weeks
  • More than 3 hours strenuous sport activity per week
  • History of abuse of drugs, alcohol or medication
  • Smoking cessation within the 6 months prior to this study
  • Incompliance due to language difficulties
  • Participation in another study during the last 4 weeks
  • Clinically relevant excursions of safety parameters

Treatment and study plan

Zenoctil

Dietary Supplement

3 tablets 2 times daily

Placebo

Other

3 tablets 2 times daily

Primary outcomes

  1. Change in Mean Body Weight (kg)

    Time frame: 12 weeks

    Change in mean body weight at week 12 compared to baseline.

  2. Change in Mean Body Fat (kg)

    Time frame: 12 weeks

    Change in mean body fat at week 12 compared to baseline

Secondary outcomes

  1. Number of Subjects Who Lost at Least 3% of Baseline Body Weight

    Time frame: 12 weeks

  2. Changes in Waist Circumference (cm)

    Time frame: 12 weeks

  3. Changes in Hip Circumference

    Time frame: 12 weeks

  4. Changes in Waist-hip-ratio

    Time frame: 12 weeks

  5. Changes in Body Fat Content (%)

    Time frame: 12 weeks

  6. Changes in Hunger, Eating, and Food-craving Related Items From the Control of Eating Questionnaire (COEQ)

    Time frame: 12 weeks

  7. Subjects' Global Feeling of Satiety

    Time frame: 12 weeks

    Subject's feeling of satiety (subsequent to the three main meals) is judged globally by the subjects on the basis of a 4 point rating scale: 0 = "no"; 1 = "slightly", 2 = "moderate" and 3 = "strong".

  8. Changes in Body Fat Free Mass (kg)

    Time frame: 12 weeks

  9. Global Evaluation of Safety by Investigators

    Time frame: 12 weeks

    The investigators evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".

  10. Global Evaluation of Safety by Subjects

    Time frame: 12 weeks

    The subjects evaluate independently the safety of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".

  11. Global Evaluation of Efficacy by Subjects

    Time frame: 12 weeks

    The subjects evaluate independently the efficacy of the investigational product, using a scale with scores of "very good", "good", "moderate" and "poor".

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study title

Double-blind, Randomized, Placebo-controlled, Bicentric Study to Evaluate the Safety and Efficacy of Zenoctil in Reducing Body Weight of Overweight Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 26, 2011
Registry last updated
Apr 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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